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Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.
A phase 2, open-label study of nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies, including temozolomide, bevacizumab, lomustine, and marizomib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A, Cohort 1: nab-sirolimus in patients with recurrent high grade glioma | Experimental | nab-Sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin) was administered at 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. |
|
| Arm A, Cohort 2: nab-sirolimus + temozolomide (TMZ) in patients with recurrent high grade glioma | Experimental | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle). Temozolomide (PO at 50 mg/m2 daily) |
|
| Arm A, Cohort 3: nab-sirolimus + bevacizumab in patients with recurrent high grade glioma | Experimental | nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle). Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle). |
|
| Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade glioma | Experimental | nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. CCNU was administered PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks). |
|
| Arm A, Cohort 5: nab-sirolimus + marizomib (MRZ) in patients with recurrent high grade glioma |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-sirolimus | Drug | nab-sirolimus, single agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology [RANO]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. | Through study completion (up to 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Median PFS | Progression-free Survival defined as number of months from the date of the first dose of study drug to the first observation of a disease progression or death due to any cause. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids. |
Not provided
Inclusion Criteria Specific for Arm A
Inclusion Criteria Specific for Arm B
Exclusion Criteria Common for Both Arms A and B
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | United States | ||
| Hoag Memorial Hospital Presbyterian |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | nab-sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin): 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. Two dose reduction levels allowed for toxicities: 75 mg/m2 and 60 mg/m2 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2019 |
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| Experimental |
nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered at 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered approximately 10 minutes after the end of the nab-sirolimus infusion. |
|
| Arm B: nab-sirolimus + temozolomide + radiotherapy in patients with newly diagnosed glioblastoma | Experimental | Induction Treatment (4 weeks) with nab-sirolimus (60 mg/m2 IV weekly); followed by Concomitant Treatment (standard of care; 2 cycles): nab-sirolimus (60 mg/m2 IV on Days 8 and 15 of every 21-day cycle) in combination with TMZ (75 mg/m2 PO daily for 6 weeks) + radiotherapy (30 × 200 cGy, 5 days/week); followed by Adjuvant Treatment (6 cycles) starting 4 weeks after Concomitant Treatment, with nab-sirolimus(60 mg/m2 IV on Days 1, 8, and 15 of every 28-day cycle) in combination with TMZ (150 mg/m2 PO daily on Days 1-5 of every 28-day cycle) |
|
| nab-sirolimus + temozolomide | Drug | temozolomide, combination |
|
|
| nab-sirolimus + bevacizumab | Drug | bevacizumab, combination |
|
|
| nab-sirolimus + lomustine | Drug | lomustine, combination |
|
|
| nab-sirolimus + marizomib (MRZ) | Drug | marizomib (MRZ), combination |
|
|
| nab-sirolimus + temozolomide + radiotherapy | Drug | temozolomide + radiotherapy, combination |
|
|
| Through study completion (up to 48 months) |
| PFS Rate at 6 Months and 12 Months | Progression-free survival rate at 6 months and 12 months was calculated as the proportion of patients who were progression-free and alive at 6 and 12 months, respectively. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids. | 6 and 12 months |
| OS | Median Overall Survival | Through study completion (up to 48 months) |
| OS at 12 Months | Overall Survival rate at 12 months | 12 months |
| Newport Beach |
| California |
| 92663 |
| United States |
| John Wayne Cancer Institute | Santa Monica | California | 90404 | United States |
| Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma |
ABI-009: IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Bevacizumab: IV infusion (90 minutes 1st dose, 60 minutes 2nd dose, and 30 minutes afterward assuming tolerability) at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle. Bevacizumab administered approximately 10 minutes after the end of the ABI-009. |
| FG002 | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Temozolomide: PO at 50 mg/m2 daily. |
| FG003 | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Lomustine (CCNU): PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks) |
| FG004 | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed for toxicities: 45, 30, and 20 mg/m2. MRZ: 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ administered approximately 10 minutes after the end of the ABI-009 infusion. |
| FG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Concomitant Treatment: starting 1 week after the completion of Induction Treatment and lasting for 6 weeks (2 cycles). ABI-009: IV at 60 mg/m2 as a 30-minute IV infusion on Days 8 and 15 of every 21-day cycle. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Temozolomide: 75 mg/m2 PO daily for 6 weeks. Focal RT: daily at 30 x 200 cGy, 5 days/week for a total dose of 60 Gy (or equivalent regimens as per RTOG guidelines) |
| COMPLETED |
|
| NOT COMPLETED |
|
Full analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | nab-sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin): 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. Two dose reduction levels allowed for toxicities: 75 mg/m2 and 60 mg/m2 |
| BG001 | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | ABI-009: IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Bevacizumab: IV infusion (90 minutes 1st dose, 60 minutes 2nd dose, and 30 minutes afterward assuming tolerability) at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle. Bevacizumab administered approximately 10 minutes after the end of the ABI-009. |
| BG002 | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Temozolomide: PO at 50 mg/m2 daily. |
| BG003 | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Lomustine (CCNU): PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks) |
| BG004 | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed for toxicities: 45, 30, and 20 mg/m2. MRZ: 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ administered approximately 10 minutes after the end of the ABI-009 infusion. |
| BG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Concomitant Treatment: starting 1 week after the completion of Induction Treatment and lasting for 6 weeks (2 cycles). ABI-009: IV at 60 mg/m2 as a 30-minute IV infusion on Days 8 and 15 of every 21-day cycle. Three dose reduction levels allowed: 45, 30, and 20 mg/m2. Temozolomide: 75 mg/m2 PO daily for 6 weeks. Focal RT: daily at 30 x 200 cGy, 5 days/week for a total dose of 60 Gy (or equivalent regimens as per RTOG guidelines) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ORR | Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology [RANO]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of patients | Through study completion (up to 48 months) |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Median PFS | Progression-free Survival defined as number of months from the date of the first dose of study drug to the first observation of a disease progression or death due to any cause. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids. | Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | Through study completion (up to 48 months) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Rate at 6 Months and 12 Months | Progression-free survival rate at 6 months and 12 months was calculated as the proportion of patients who were progression-free and alive at 6 and 12 months, respectively. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids. | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of patients | 6 and 12 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS | Median Overall Survival | Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | Through study completion (up to 48 months) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS at 12 Months | Overall Survival rate at 12 months | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of patients | 12 months |
|
Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) | 7 | 7 | 0 | 7 | 7 | 7 |
| EG001 | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily) | 4 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle) | 8 | 9 | 0 | 9 | 8 | 9 |
| EG003 | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks) | 4 | 4 | 1 | 4 | 4 | 4 |
| EG004 | Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) | 10 | 10 | 0 | 10 | 10 | 10 |
| EG005 | Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles | 19 | 26 | 1 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Myelosuppression (thrombocytopenia) | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Myelossupression (neutropenia) | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis | Gastrointestinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Myelosuppression (thrombocytopenia) | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Myelosuppression (anemia) | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Myelossupression (neutropenia) | Blood and lymphatic system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | NCI CTCAE v5.0 | Systematic Assessment |
| |
| ALT | Investigations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| AST | Investigations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | NCI CTCAE v5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v5.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aadi Medical Information | Aadi Bioscience, Inc. | 1-888-246-2234 | MedInfo@aadibio.com |
| Nov 4, 2023 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D000068258 | Bevacizumab |
| D008130 | Lomustine |
| C475865 | marizomib |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks) |
| OG004 | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) |
| OG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles |
|
|
| OG003 | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks) |
| OG004 | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) |
| OG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles |
|
|
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
| OG004 | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) |
| OG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles |
|
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nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
| OG004 | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) |
| OG005 | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles |
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